Model Number SN6AT4 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Endophthalmitis (1835); Necrosis (1971); Vitrectomy (2643)
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Event Date 12/17/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product evaluation: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information was requested and received.Zip code is not indicated at this time.The manufacturer internal reference number is: (b)(4).
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Event Description
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A doctor reported endophthalmitis following an intraocular lens (iol) implant procedure.The patient was transferred to another hospital where a vitrectomy was performed.The lens was removed and a culture was performed.The bacterial inspection revealed that enterococci was detected from the vitreous and none from the iol.During the initial postoperative visit, the anterior chamber of the patient was filled with fibrins and retinal necrosis was observed, however, now the fundus can be observed and the patient can recognize colors.
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Manufacturer Narrative
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Product evaluation: the lens was returned adhered with dried solution to the inside of a capped centrifuge tube.Clumps and patterns of dried solution are observed on the lens, seen on the optic center and on the haptics.There was no damage observed to the iol.Associated products were not provided.It is unknown if qualified products were used.The root cause could not be determined for the reported complaint.Based on the manufacturing product history and batch record reviews for the iol, there were no manufacturing process anomalies noted.No damage was observed to the returned sample.No potential contributing factors could be identified related to the iol.Information in the file indicated the iol had been explanted and was cultured at the subcontractor of the hospital.The file indicated that the sales rep obtained information from the physician of the hospital that ¿the bacterial inspection result revealed that enterococci were detected from vitreous sample and none from iol¿.The translated questionnaire provided by a health care professional for this patient indicated bacterial endophthalmitis.Enterococcus (determined at another clinic).The comment section of the translated questionnaire also stated that ¿endophthalmitis seemed to develop two days after the surgery; however, eye pain, ciliary hyperaemia or hypopyon were not seen until the patient was introduced to the hospital.It must have progressed rapidly in the vitreous body.I could not deny the possibility that bacteria were initially adhered to the iol, thus i¿ve requested the manufacturer to investigate the lens.¿ the manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was provided indicating that the initial postoperative exam revealed corneal opacity, increase in iop and ciliary hyperaemia or discharge in anterior chamber and angles.The patient was hospitalized due to rapid progression of inflammation into the vitreous body.The surgeon could not deny the possibility that bacteria was initially adhered to the iol.
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Search Alerts/Recalls
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